Actively Recruiting
A Multicenter Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Zigakibart in Adults With Primary IgA Nephropathy
Led by Novartis Pharmaceuticals · Updated on 2026-06-01
220
Participants Needed
18
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the long-term safety and tolerability of zigakibart in adults with primary immunoglobulin A nephropathy (IgAN), a kidney disease. This open-label extension phase 3 study includes patients who previously participated in earlier zigakibart studies, aiming to understand how well the drug works and how safe it is over an extended period. Participants in this study will receive zigakibart as a solution for subcutaneous injection, given at a dose of 600 mg every two weeks. This trial follows patients who completed previous zigakibart studies, providing ongoing treatment and monitoring their response and safety over time. During the study, participants will have regular visits for safety checks, laboratory tests, and measurements of kidney function and protein levels in urine. Researchers will monitor adverse events, serious side effects, drug levels in the blood, antibody formation, and changes in immunoglobulin levels. The study may last up to approximately five years, with follow-up assessments continuing 24 weeks after the last dose to ensure safety and evaluate long-term effects.
CONDITIONS
Brief Title
Open-label Extension Study of Zigakibart in Adults With IgA Nephropathy.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent prior to participation in the extension study.
- Completion of a previous zigakibart parent study in IgA nephropathy.
- Investigator's judgment that the participant may benefit from open-label zigakibart 600 mg subcutaneous injection every two weeks.
- Adults aged 18 to 100 years.
You will not qualify if you...
- Premature withdrawal from previous zigakibart parent studies in IgA nephropathy.
- Receiving chronic dialysis for 30 days or more, or requiring kidney transplantation at study start.
- Acute kidney injury within 4 weeks before first treatment in the extension study.
- Diagnosis or suspicion of rapidly progressive glomerulonephritis or other glomerulopathy at study start.
- Receipt of live vaccination within 12 weeks before first treatment or planned within 6 months after last dose.
- Use of systemic corticosteroids or other immunosuppressive therapies for more than 2 weeks in the 12 weeks before first treatment; rituximab use within 180 days before first treatment.
- Current severe infection or history of recurrent severe infections.
- Newly diagnosed positive serology for hepatitis A, B, C, or HIV (with some exceptions).
- Newly diagnosed malignancy, except certain low-risk skin or cervical cancers.
- Pregnancy, breastfeeding, or intent to become pregnant or donate sperm during the study and up to 24 weeks after last dose.
- Any other significant medical or psychiatric condition posing unfavorable risk-benefit.
- Confirmed low IgG levels below 3 g/L before first treatment.
- Women of child-bearing potential not using highly effective contraception during and 24 weeks after treatment.
- Sexually active males unwilling to use highly effective contraception or donate sperm during and 24 weeks after treatment.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 5 years
Participants receive zigakibart as a subcutaneous injection every two weeks to evaluate long-term safety and tolerability.
Multiple visits including Baseline, Week 2, Week 4, Week 24, Week 48, Week 72, Week 96, and every 24 weeks thereafter
Duration - 24 weeks
Participants are monitored for adverse events and safety for 24 weeks after the last administration of the study treatment.
Visits as needed during the 24-week safety monitoring period
Trial Site Locations
Total: 18 locations
1
Colorado Kidney Care Nephrology
Denver, Colorado, United States, 80230
Actively Recruiting
2
Nephrology Associates Of Central FL
Orlando, Florida, United States, 32806
Actively Recruiting
3
NY Nephrology
Clifton Park, New York, United States, 12065
Actively Recruiting
4
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
5
Knoxville Kidney Center Pllc
Brentwood, Tennessee, United States, 37027-4528
Actively Recruiting
6
Dallas Renal Group
Dallas, Texas, United States, 75230
Actively Recruiting
7
Dallas Renal Group
Dallas, Texas, United States, 75230
Actively Recruiting
8
Novartis Investigative Site
Caba, Buenos Aires, Argentina, 3375
Actively Recruiting
9
Novartis Investigative Site
La Plata, Buenos Aires, Argentina, B1902COS
Actively Recruiting
10
Novartis Investigative Site
Buenos Aires, Buenos Aires F.D., Argentina, 1280
Actively Recruiting
11
Novartis Investigative Site
Santa Fe, Argentina, S3000EPV
Actively Recruiting
12
Novartis Investigative Site
Kogarah, New South Wales, Australia, 2217
Actively Recruiting
13
Novartis Investigative Site
Kuantan, Pahang, Malaysia, 25100
Actively Recruiting
14
Novartis Investigative Site
Kuala Lumpur, Malaysia, 59100
Actively Recruiting
15
Novartis Investigative Site
Cheonan, Chungcheongnam-do, South Korea, 330-721
Actively Recruiting
16
Novartis Investigative Site
Guri-si, Gyeonggi-do, South Korea, 471-701
Actively Recruiting
17
Novartis Investigative Site
Seongnam-si, Gyeonggi-do, South Korea, 13620
Actively Recruiting
18
Novartis Investigative Site
Seoul, Seoul, South Korea, 03080
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
N
Novartis Pharmaceuticals
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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